💬In plain words
What the trial is, and whether it could suit you
This Phase 2 study will evaluate whether multiple doses of cebranopadol suppress opioid withdrawal signs and symptoms compared with placebo in adults with chronic pain who are physically dependent on prescribed opioids. Participants whose physical dependence is confirmed will be assigned by chance to one of two cebranopadol dose regimens or matching placebo. The study will also evaluate pain, safety and tolerability, and cebranopadol pharmacokinetics.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Key Inclusion Criteria:
* Adults 18-65 years with BMI 18.0-40.0 kg/m² and weight ≥50 kg.
* Chronic daily pain for ≥6 months due to chronic low back pain, hip/knee osteoarthritis, or painful peripheral neuropathy.
* Prescribed opioid use ≥5 days/week for ≥3 months within the prior 6 months, generally 50-90 MME/day; \>90 MME/day may be allowed with Sponsor/designee approval.
* Generally in good health and able to comply with study procedures, including opioid withdrawal and inpatient confinement.
* Meet protocol-specified reproductive and contraception requirements.
* Able to provide informed consent and complete study assessments in English.
* Physical opioid dependence confirmed by protocol-defined COWS and/or SOWS criteria before randomization.
Key Exclusion Criteria:
* Clinically significant medical or psychiatric condition that could compromise participant safety or study validity.
* Protocol-specified excluded pain, neurologic, spinal, infectious, or neoplasm-related conditions.
* QTcF \>450 ms in males or \>470 ms in females, other torsade de pointes risk factors, or use of QT-prolonging medications.
* Substance use disorder other than opioid, nicotine, or caffeine use disorder, or positive testing for prohibited drugs/alcohol, subject to the protocol-specified cannabinoid exception.
* Positive HIV, hepatitis B surface antigen, or hepatitis C antibody test.
* Suicidal ideation or active suicidality within the past 2 years.
* Use of prohibited medications or inability to meet protocol-specified medication washout requirements.
* Pregnant or breastfeeding or planning pregnancy within 30 days after the last study-drug dose.
* Significant adverse reaction to naloxone or related opioids/opioid antagonists.
* Unable to undergo IV catheter placement or otherwise considered unsuitable or unlikely to comply with the protocol.
* Legal, employment, or other circumstances that could interfere with study participation or compliance.
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